Following the reported success of the open-label Phase II study of Hepko-V5 oral immunotherapeutic vaccine conducted in 75 patients with late stage hepatocellular carcinoma (HCC), Hepko-V5 is now in Phase III trial stage. Based on encouraging preliminary data, Hepko-V5 has received orphan drug designation from the U.S. Food and Drug Administration (FDA), which clears the path toward approval in U.S.A. market, and a Phase II trial in patients with cholangiocarcinoma -- the second most common form of liver cancer affecting bile ducts -- has been initiated.

Additionally, our Licensor last week announced the Phase II, open-label, immunotherapy trial in patients with pancreatic cancer (See registration NCT03165591) that will seek to engage at least 30 patients with inoperable and chemotherapy-failed pancreatic cancer for a 3-month trial. The main inclusion criteria are higher than normal baseline levels of CA 19.9 tumor antigen.

Key Capital believes the planned pancreatic cancer trial will prove as groundbreaking as the Hepko-V5 Immunotherapy demonstrated in cases of advanced and terminal liver cancer.

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